Packaging for solid dosage forms of melatonin with a high citric acid concentration
Melatonin tablets with a high concentration of citric acid are packaged in a blister package that enhances storage stability. Such a packaging material includes a blister film forming a cavity holding the tablet therein. The blister film includes a polyvinyl chloride (PVC) film having a thickness of 180 μm to 270 μm coated with a polyvinylidene chloride (PVDC) coating having a coating weight of 110 g/m 2 to 130 g/m 2 . An aluminum foil lid closes the cavity and encapsulates the tablet within the blister film and lid. The lid has a thickness of 20 μm to 30 μm.
1. A product comprising:
an oral tablet dosage form including melatonin and citric acid in a polymer matrix;
a blister film forming a cavity holding the tablet therein, the blister film including a polyvinyl chloride (PVC) film having a thickness of 180 μm to 270 μm coated with a polyvinylidene chloride (PVDC) coating having a coating weight of 110 g/m 2 to 130 g/m 2 ; and
an aluminum foil lid closing the cavity and encapsulating the tablet within the blister film and lid, the lid having a thickness of 20 μm to 30 μm.
2. The product of claim 1 , wherein the PVC film has a thickness of 190 μm to 260 μm.
3. The product of claim 1 , wherein the PVDC coating has a coating weight of about 120 g/m 2 .
4. The product of claim 1 , wherein the lid has a thickness of about 25 μm.
5. The product of claim 1 , wherein the PVC film has a thickness of 190 μm to 260 μm, the PVDC coating has a coating weight of about 120 g/m 2 , and the lid has a thickness of about 25 μm.
6. The product of claim 1 , wherein the tablet includes an opalescent outer coating containing mica particles as a light barrier.
7. The product of claim 1 , wherein the tablet dosage form includes at least 5% w/w citric acid.
8. A product comprising:
an oral tablet dosage form including melatonin and citric acid in a polymer matrix;
the tablet being enclosed in a packaging material consisting of:
a blister film forming a cavity holding the tablet therein, the blister film including a polyvinyl chloride (PVC) film having a thickness of 180 μm to 270 μm coated with a polyvinylidene chloride (PVDC) coating having a coating weight of 110 g/m 2 to 130 g/m 2 ; and
an aluminum foil lid closing the cavity and encapsulating the tablet within the blister film and lid, the lid having a thickness of 20 μm to 30 μm and a heatseal coating.
9. The product of claim 8 , wherein the PVC film has a thickness of 190 μm to 260 μm.
10. The product of claim 8 , wherein the PVDC coating has a coating weight of about 120 g/m 2 .
11. The product of claim 8 , wherein the lid has a thickness of about 25 μm.
12. The product of claim 8 , wherein the PVC film has a thickness of 190 μm to 260 μm, the PVDC coating has a coating weight of about 120 g/m 2 , and the lid has a thickness of about 25 μm.
13. The product of claim 8 , wherein the tablet includes an opalescent outer coating containing mica particles as a light barrier.
14. The product of claim 8 , wherein the tablet dosage form includes at least 5% w/w citric acid.